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Wednesday 27 May 2009

Will Seroxat scandal damage GSK? - not likely as CSM Expert Working Group on SSRI study 1987-2000 shows


7.4.2 Suicidal thoughts and self-harm

These analyses included the following terms which have been grouped under the overall term ‘suicidal thoughts and self-harm’: suicide accomplished, suicide attempt, suicidal ideation, aggravated suicidal ideation, parasuicide, non-accidental overdose and thoughts of self-harm. Data were analysed since marketing up to September 2003.

It is recognised that media interest can stimulate reporting through the Yellow Card Scheme, and the publicity surrounding the safety of fluoxetine in 1990 caused an increase in reporting of suicidal thoughts and self-harm associated with fluoxetine. There was also some effect on reporting rates for other SSRIs. The reporting rate of suicidal behaviour with fluoxetine then dropped between 1991 and 1993, and continued to fall gradually until 1998. In the years 1995 to 1998, the reporting rates for fluoxetine, paroxetine and sertraline were very similar, figure 7.2. This argues against this phenomenon being a particular adverse reaction to fluoxetine. Reporting rates for venlafaxine were comparatively higher between 1995 and 1998 (figure 7.3), although this coincides with the first few years of marketing of this drug. After 1998, reporting rates for venlafaxine fell to similar level as the other SSRIs.



source - CSM Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants report

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